This document provides a quick reference guide to medical device and digital health regulation. It discusses what regulation aims to achieve, how it impacts companies, and some tips. Regulation serves as a barrier to market through requiring product approval. It affects a company's entire product lifecycle and involves regulatory affairs, quality affairs, and clinical affairs. Regulation impacts time to market and costs, so companies should have a valid regulatory strategy to increase their return on investment. The document also provides a brief overview of how medical devices are regulated compared to digital health products.